BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE ELECTRODE STORE

    MDR report key: 12186197 · Received July 17, 2021

    Report

    Report Number
    2022388-2021-00001
    Event Type
    Malfunction
    Date Received
    July 17, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 6, 2021
    Manufacturer
    THE ELECTRODE STORE
    Product Code
    GXZ
    UDI-DI
    00816022022131
    PMA / PMN Number
    K020910
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EEG NEEDLE ELECTRODE DEVICE WAS CLEARED IN THE US IN 2002, ON 510(K) #K020910. SINCE THAT TIME THERE HAVE BEEN APPROXIMATELY (B)(4) OF THE DEVICES SOLD AND USED PER AVERAGE YEAR - OVER (B)(4) DEVICES IN TOTAL. ALL ARE OF THE SAME DESIGN AND USE THE SAME STAINLESS STEEL NEEDLE COMPONENT FROM OUR LONG-TERM SUPPLIER. TO OUR KNOWLEDGE, NO OTHER INSTANCES OF THE NEEDLE BREAKING HAVE OCCURRED OR BEEN REPORTED. THE ACTUAL UNIT THAT BROKE WAS DISCARDED BY THE USER, BUT WE HAVE TESTED A NUMBER OF DEVICES FROM THE SAME LOT RETURNED TO US BY THE USER. THE RETURNED UNITS WERE ALL WITHIN DESIGN SPECS, PASSED VARIOUS TESTS WITH NO BREAKAGES, AND EXHIBITED NO DIFFERENCES COMPARED TO A LARGER CONTROL GROUP. OUR TESTING CONFIRMED THAT THE NEEDLES ARE VERY DIFFICULT TO BREAK, EVEN UNDER MUCH MORE RIGOROUS TEST STRESSES THAN THEY EXPERIENCE DURING NORMAL USE IN SKIN AND MUSCLE TISSUE.

    Description of Event or Problem · 1

    THE TIP OF A STAINLESS STEEL STERILE DISPOSABLE MONOPOLAR EEG NEEDLE ELECTRODE BROKE OFF FROM THE NEEDLE SHAFT DURING NEEDLE ELECTROENCEPHALOGRAPHY (EEG) DIAGNOSTIC EXAMINATION OF A (B)(6)-OLD NEONATE. THE PATIENT (A BABY APPROXIMATELY (B)(6) OLD) HAD UNDERGONE NEEDLE ELECTROENCEPHALOGRAPHY (EEG) MONITORING FOR DIAGNOSIS OF POTENTIAL NEUROLOGICAL OR SEIZURE DISORDERS IN THE NEONATAL UNIT. THE NEEDLE ELECTRODES WERE REMOVED AFTER AN UNKNOWN DURATION, PRIOR TO THE PATIENT UNDERGOING A ROUTINE MRI DIAGNOSTIC SCAN. THE MRI SCAN REVEALED SOMETHING DARK ON THE RIGHT SIDE WHICH CAN BE INDICATIVE OF A FOREIGN OBJECT SUCH AS A METAL. AN X-RAY CONFIRMED THE PRESENCE OF THE TIP OF ONE OF THE STAINLESS STEEL NEEDLES, MEASURED TO BE APPROXIMATELY 3MM LONG AND 1MM TO 2MM BELOW THE SURFACE OF THE SKIN AND ROUGHLY PARALLEL TO THE SCALP. IT WAS EVIDENT THAT THE 3MM TIP - WHICH IS THE SHARP END OF THE NEEDLE AND REPRESENTS APPROXIMATELY 25% OF THE EXPOSED 12MM LENGTH OF THE NEEDLE - HAD AT SOME POINT BETWEEN INSERTION AND REMOVAL OF THE NEEDLE BROKEN OFF FROM THE STAINLESS STEEL NEEDLE SHAFT WHICH WAS STILL CONNECTED TO THE ELECTRODE HANDLE AND WIRE. IN EXAMINING THE PATIENT'S SKIN SURFACE NEAR THE LOCATION OF THE NEEDLE, THE SYMPTOMS OF REDNESS AND SWELLING WERE OBSERVED. AT THE TIME THE NEEDLE ELECTRODES WERE INITIALLY REMOVED, THE MEDICAL PROFESSIONAL DID NOT OBSERVE (SEE) ANY DAMAGE OR BREAKAGE, AND THE NEEDLES APPEARED TO BE INTACT. AFTER THE LATER DISCOVERY OF THE BROKEN NEEDLE TIP, THE MEDICAL PROFESSIONAL DID RECALL THAT ONE OF THE NEEDLE ELECTRODES (IT WAS BELIEVED TO BE ONE WITH THE RED WIRE THAT BROKE; REFERENCE PART NUMBER PRO-ER) SEEMED MORE DIFFICULT THAN USUAL TO REMOVE FROM THE PATIENT. BECAUSE THE NEEDLE TIP WAS SUBMERGED BENEATH THE SURFACE OF THE SKIN, IT REQUIRED THAT THE PATIENT BE MOVED FROM THE NEONATAL UNIT TO A SURGICAL CENTER AT AN AFFILIATE HOSPITAL, WHERE A MINOR SURGERY WAS SUCCESSFULLY PERFORMED TO REMOVE THE NEEDLE TIP. THE PATIENT MADE A FULL RECOVERY FROM THIS NEEDLE BREAKAGE INCIDENT, AND IS NOT EXPECTED TO HAVE ANY ADDITIONAL ILL EFFECTS, PERMANENT DAMAGE OR HARM RELATING TO THE NEEDLE BREAKAGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1083351 THE ELECTRODE STORE SUBDERMAL NEEDLE ELECTRODE FOR ELECTROENCEPHALOGRAPHY GXZ THE ELECTRODE STORE PRO-ER 0320060 00816022022131

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DA Required Intervention